- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505914
Effects of Breathing Exercises on Cognition in Older Adults
Comparing Different Breathing Exercises Added to Balance Training on Cognitive and Functional Outcomes in Elderly Population
The goal of this interventional clinical trial is to investigate the effects of breathing exercises added to balance training on cognitive function in individuals aged 65 years and older.
The main questions it aims to answer are:
Do breathing exercises affect cognition? Do different breathing exercises affect cognition in different ways?
Researchers will administer two different breathing protocols and evaluate cognition before and after each protocol.
Participants will take part in an 8-week program consisting of sessions that include 30 minutes of balance-based exercises and 15 minutes of breathing exercises. Sessions will be held twice weekly under the supervision of a physical therapist.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Deema Almurad
- Phone Number: 00905010492000
- Email: deemaalmurad@gmail.com
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- Müzeyyen Keçeli Aile Sağlığı Merkezi
-
Contact:
- Sami Sabri Bulgurlu
- Phone Number: 00902128035189
- Email: muzeyyenkeceliasm@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 65 years and older
- Able to walk independently
- Suitable for light to moderate physical activity
- Willing and able to attend 2 sessions per week for 8 weeks
Exclusion Criteria:
- Underwent surgery within the last 6 months
- Currently participating in another structured rehabilitation program
- Neurological disorders that significantly restrict mobility (e.g., Parkinson's disease, stroke)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inspiratory Muscle Training
|
A structured balance-based exercise program (30 minutes per session) designed to reduce fall risk and improve functional performance.
Training performed using a threshold device to strengthen inspiratory muscles for 15 minutes with intensity set individually and progressively adjusted.
|
|
Experimental: Breathing Exercises
|
A structured balance-based exercise program (30 minutes per session) designed to reduce fall risk and improve functional performance.
Breathing exercises aimed at improving lung function and respiratory health, including diaphragmatic breathing and pursed-lip breathing.
Exercises will be performed for 15 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: From enrollment to the end of intervention at 8 weeks
|
The Montreal Cognitive Assessment (MoCA) is used to assess global cognitive function.
The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
|
From enrollment to the end of intervention at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spirometry Parameters (FEV1, FVC, FEV1/FVC Ratio)
Time Frame: From enrollment to the end of intervention at 8 weeks
|
Spirometry will be used to assess pulmonary function, including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and the FEV1/FVC ratio.
Higher values indicate better pulmonary function.
|
From enrollment to the end of intervention at 8 weeks
|
|
Maximal Inspiratory and Expiratory Pressures (MIP/MEP)
Time Frame: From enrollment to the end of intervention at 8 weeks
|
Respiratory muscle strength will be assessed using maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements.
Higher values indicate greater respiratory muscle strength.
|
From enrollment to the end of intervention at 8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zelano C, Jiang H, Zhou G, Arora N, Schuele S, Rosenow J, Gottfried JA. Nasal Respiration Entrains Human Limbic Oscillations and Modulates Cognitive Function. J Neurosci. 2016 Dec 7;36(49):12448-12467. doi: 10.1523/JNEUROSCI.2586-16.2016.
- Johannknecht M, Kayser C. The influence of the respiratory cycle on reaction times in sensory-cognitive paradigms. Sci Rep. 2022 Feb 16;12(1):2586. doi: 10.1038/s41598-022-06364-8.
- Vanutelli ME, Grigis C, Lucchiari C. Breathing Right... or Left! The Effects of Unilateral Nostril Breathing on Psychological and Cognitive Wellbeing: A Pilot Study. Brain Sci. 2024 Mar 23;14(4):302. doi: 10.3390/brainsci14040302.
- Song F,Ding K,Sun W,Huang Q,Jiang R,Xiang H,Sun M
- Braendholt M, Kluger DS, Varga S, Heck DH, Gross J, Allen MG. Breathing in waves: Understanding respiratory-brain coupling as a gradient of predictive oscillations. Neurosci Biobehav Rev. 2023 Sep;152:105262. doi: 10.1016/j.neubiorev.2023.105262. Epub 2023 Jun 3.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025/712
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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